Medtech Summit
Clayton Hotel Burlington Road Leeson Street Upper, Dublin, IrelandJoin us at Medtech Summit in Dublin, Ireland Criterion Edge provides medical and regulatory writing services for the […]
Join us at Medtech Summit in Dublin, Ireland Criterion Edge provides medical and regulatory writing services for the […]
Ask the Expert: The Role of Regulatory Affairs in the Clinical and Performance Evaluation Process Regulatory Affairs is […]
Bridging the Gaps: Determining Clinical Data Sufficiency to Demonstrate Conformity with GSPRs What do I do if there […]
Demonstration of Sufficient Evidence and Regulatory Strategy Alignment in the Clinical Evaluation Process In the first part of […]
Clinical Evaluation Report Critical Concepts: Effectively Telling the Story of the CER - Focus on S&P Objectives, Acceptance […]
Ask the Expert: Clinical Evaluation Report Template and Critical Concepts This session is presented from the point of […]
Critical Concepts: The Role of Post Market Surveillance in Establishing Data Sufficiency In this webinar, we will review […]
Critical Concepts: A Deep Dive into MDR and IVDR Device Classification and Data Collection Strategies In September 2022, […]
New Requirements for In Vitro Diagnostics: Lessons Learned from the AAMI/FDA/BSI Annual Conference The In Vitro Diagnostics Regulation […]
Plain Language Communication in Healthcare - Part 1: Understanding the Requirements and Challenges of Plain Language Content Creation […]
The goal of performance evaluation is to show that your IVD performs as intended and meets the acceptance […]
In case you are wondering if Medical Device Software (MDSW/SaMD) and digital health content is a hot topic, […]
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